FDA Warns of Issue with Impella Blood Pump Controllers

Abiomed, part of Johnson & Johnson MedTech, has identified an issue that may affect the detection of its Impella pumps when connected to their controllers, according to an alert put out by the US Food and Drug Administration on Tuesday.

The agency is aware that the device manufacturer sent a June 23 letter to customers recommending updated instructions for use for all Automated Impella Controllers (AICs), the main control interface for the Impella catheter, in response to the detection problem. “There is no visual alarm displayed on the AIC screen to indicate the detection issue,” the FDA noted.

If this occurs, hemodynamic support may be inadequate, which “may not be well tolerated and may lead to life-threatening injuries” in patients with cardiogenic shock, the agency said.

A Johnson & Johnson MedTech spokesperson said that a review of complaints submitted between January 2021 and May 2025 indicated a 0.02% rate of occurrence for the issue. As of June 13, Abiomed had received reports of three deaths, and no additional serious injuries, tied to the problem.

In its letter, the company recommended solutions, including having a backup AIC available in case of device failure and taking certain steps depending on whether the issue occurs during a console-to-console transfer or the start of a case.

“Importantly, this is not a product removal,” the company spokesperson said. “The AIC and Impella pumps remain on the market and available for patient care.”

The FDA said that it “is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.”